Diagnosis of Pathological Complete Response by Vacuum-assisted Biopsy After Neoadjuvant Chemotherapy in Breast Cancer

NCT02948764 | Completed DMC

• 1 other identifier: 2
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of the study is to evaluate the potential of a minimal invasive, vacuum-assisted biopsy (VAB) to reliably diagnose a pathological complete response (pCR) in the breast after neoadjuvant chemotherapy (NACT) in breast cancer patients. The study is designed as a multicenter, confirmative, one-armed, intra-individually-controlled, open, diagnostic trial, in which we aim to confirm the applicability of preoperative VAB in patients after NACT. Furthermore, we aspire to quantify the rate of concordant pathological findings (pCR yes / no) in biopsy and surgical specimen.

Conditions

Breast Neoplasms

Keywords

breast cancer; vacuum-assisted biopsy; pathological complete response

Outcome Measures

Primary Outcomes (1)

• false negative VAB results, reported as the false negative rate (= FNR)

  non-detected residual tumor by VAB (=index test) compared to breast surgery (=reference test): FNR = rate of patients with non-detected residual tumor by VAB compared to breast surgery Residual tumor is defined as a positive result; in surgical specimen as well as in VAB.

  after breast surgery, up to 6 weeks after VAB

Secondary Outcomes (3)

• negative predictive value (NPV)

  after breast surgery, up to 6 weeks after VAB

• positive predictive value (PPV)

  after breast surgery, up to 6 weeks after VAB

• false positive rate (FPR)

  after breast surgery, up to 6 weeks after VAB

Study Arms (1)

single-arm study

OTHER

This project is designed as a one-armed diagnostic study. Every patient included in the study will undergo the same diagnostic test, the vacuum-assisted biopsy, after NACT and before surgery according to guidelines.

Device: Vacuum-Assisted Biopsy

Interventions

Vacuum-Assisted Biopsy DEVICE

The vacuum-assisted (7-10G), minimal invasive biopsy (VAB), either guided by ultrasound, or by mammography (stereotaxy) during the second trial visit (V2) will be performed once. In analogy to the German S3 guideline on primary breast cancer management we recommend to take at least 12 biopsies with 10G needles or less in case of larger needle sizes.

Also known as: minimal invasive biopsy

single-arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with primary breast cancer after Neoadjuvant Chemotherapy (NACT) treatment which has been performed for at least 12 weeks and resulted in cPR or cCR (see below).
• \>/=18 years
• any cT and cN stage, except cT4 stages
• any routine breast cancer surgical intervention planned according to guidelines (breast conservation or mastectomy)
• Residual intramammary target lesion or clip marker is visible in ultrasound and / or mammography
• Diagnosis of imaging complete or partial response according to RECIST 1.1 by at least mammography or ultrasound, according to local routine)
• In case of multicentric disease: confirmation of the same tumorbiological subtype defined by immunohistology in at least 2 lesions.
• Ability of subject to understand character and individual consequences of the clinical trial.
• Written informed consent (must be available before enrolment in the trial).

You may not qualify if:

• Palliative or recurrent breast cancer
• in case of clip marker = target lesion: dislocation of marker (\>5mm distance to the initial lesion border at the time of clip placement)
• contraindication for VAB or associated procedures (e.g. local anesthesia)
• Pregnancy and lactation
• held in an institution by legal or official order
• legally incapacitated.

Sponsors & Collaborators

• Heidelberg University: lead
• German Research Foundation: collaborator

Study Sites (1)

University Breast Unit, Department of Gynecology, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (5)

• Schaefgen B, Mati M, Sinn HP, Golatta M, Stieber A, Rauch G, Hennigs A, Richter H, Domschke C, Schuetz F, Sohn C, Schneeweiss A, Heil J. Can Routine Imaging After Neoadjuvant Chemotherapy in Breast Cancer Predict Pathologic Complete Response? Ann Surg Oncol. 2016 Mar;23(3):789-95. doi: 10.1245/s10434-015-4918-0. Epub 2015 Oct 14.

  PMID: 26467456 RESULT

• Heil J, Kummel S, Schaefgen B, Paepke S, Thomssen C, Rauch G, Ataseven B, Grosse R, Dreesmann V, Kuhn T, Loibl S, Blohmer JU, von Minckwitz G. Diagnosis of pathological complete response to neoadjuvant chemotherapy in breast cancer by minimal invasive biopsy techniques. Br J Cancer. 2015 Dec 1;113(11):1565-70. doi: 10.1038/bjc.2015.381. Epub 2015 Nov 10.

  PMID: 26554654 RESULT

• Pfob A, Sidey-Gibbons C, Rauch G, Thomas B, Schaefgen B, Kuemmel S, Reimer T, Hahn M, Thill M, Blohmer JU, Hackmann J, Malter W, Bekes I, Friedrichs K, Wojcinski S, Joos S, Paepke S, Degenhardt T, Rom J, Rody A, van Mackelenbergh M, Banys-Paluchowski M, Grosse R, Reinisch M, Karsten M, Golatta M, Heil J. Intelligent Vacuum-Assisted Biopsy to Identify Breast Cancer Patients With Pathologic Complete Response (ypT0 and ypN0) After Neoadjuvant Systemic Treatment for Omission of Breast and Axillary Surgery. J Clin Oncol. 2022 Jun 10;40(17):1903-1915. doi: 10.1200/JCO.21.02439. Epub 2022 Feb 2.

  PMID: 35108029 DERIVED

• Pfob A, Sidey-Gibbons C, Lee HB, Tasoulis MK, Koelbel V, Golatta M, Rauch GM, Smith BD, Valero V, Han W, MacNeill F, Weber WP, Rauch G, Kuerer HM, Heil J. Identification of breast cancer patients with pathologic complete response in the breast after neoadjuvant systemic treatment by an intelligent vacuum-assisted biopsy. Eur J Cancer. 2021 Jan;143:134-146. doi: 10.1016/j.ejca.2020.11.006. Epub 2020 Dec 8.

  PMID: 33307491 DERIVED

• Heil J, Sinn P, Richter H, Pfob A, Schaefgen B, Hennigs A, Riedel F, Thomas B, Thill M, Hahn M, Blohmer JU, Kuemmel S, Karsten MM, Reinisch M, Hackmann J, Reimer T, Rauch G, Golatta M. RESPONDER - diagnosis of pathological complete response by vacuum-assisted biopsy after neoadjuvant chemotherapy in breast Cancer - a multicenter, confirmative, one-armed, intra-individually-controlled, open, diagnostic trial. BMC Cancer. 2018 Aug 25;18(1):851. doi: 10.1186/s12885-018-4760-4.

  PMID: 30144818 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joerg Heil, Professor

  University of Heidelberg University Breast Unit, Department of Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Joerg Heil

Study Record Dates

• First Submitted: October 16, 2016
• First Posted: October 28, 2016
• Study Start: March 8, 2017
• Primary Completion: May 24, 2019
• Study Completion: September 15, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)